Spinal and Bulbar Muscular Atrophy
Conditions
Brief summary
1. Change from baseline in thigh and total lean muscle volume (LMV) as assessed by whole-body MRI., 2. Number of patients with adverse events (AEs) or serious adverse events (SAEs)., 3. Number of patients discontinuing study and number of deaths., 4. Number of mild, moderate, and severe AEs
Detailed description
1. Change from baseline in 6MWT, 2. Change from baseline in modified-SBMAFRS (m-SBMAFRS), 3. Change from baseline in actigraphy-derived physical activity, 4. Change from baseline in timed up and go (TUG) test, 5. Change from baseline in grip strength as measured by handheld dynamometer (HHD), 6. Change from baseline in two-minute walk test (2MWT)
Interventions
DRUGNIDO-361 placebo tablets
DRUGNIDO-361
Sponsors
Nido Biosciences Inc.
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Change from baseline in 6MWT, 2. Change from baseline in modified-SBMAFRS (m-SBMAFRS), 3. Change from baseline in actigraphy-derived physical activity, 4. Change from baseline in timed up and go (TUG) test, 5. Change from baseline in grip strength as measured by handheld dynamometer (HHD), 6. Change from baseline in two-minute walk test (2MWT) | — |
Primary
| Measure | Time frame |
|---|---|
| 1. Change from baseline in thigh and total lean muscle volume (LMV) as assessed by whole-body MRI., 2. Number of patients with adverse events (AEs) or serious adverse events (SAEs)., 3. Number of patients discontinuing study and number of deaths., 4. Number of mild, moderate, and severe AEs | — |
Countries
Denmark, Italy
Outcome results
None listed